Ezetimibedosage

Important Dosage and Administration Information: Take VYTORIN orally once daily in the evening with or without food. Maximum recommended dosage is VYTORIN 10/40 mg once daily. VYTORIN 10/80 mg daily dosage is restricted to patients who have been taking VYTORIN 10/80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving VYTORIN 10/40 mg daily, prescribe alternative LDL-C-lowering treatment. If as dose is missed, take the missed dose as soon as possible. Do not double the next dose. Assess LDL-C when clinically appropriate, as early as 2 weeks after initiating VYTORIN, and adjust the dosage if necessary.

Adults: Recommended dosage range of 10/10 mg to 10/40 mg once daily. See full prescribing information for VYTORIN dosage modifications due to drug interactions.

Patients with Renal Impairment: Doses exceeding 10/20 mg should be used with caution and close monitoring in patients with moderate to severe renal impairment.

2.1 Important

Dosage and Administration Information Take VYTORIN orally once daily in the evening with or without food. The maximum recommended dosage is VYTORIN 10/40 mg once daily. The VYTORIN 10/80 mg daily dosage is restricted to adult patients who have been taking VYTORIN 10/80 mg daily chronically (e.g., for 12 months or more) without evidence of muscle toxicity. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving VYTORIN 10/40 mg daily, prescribe alternative LDL-C-lowering treatment. If as dose is missed, take the missed dose as soon as possible. Do not double the next dose. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating VYTORIN, and adjust the dosage if necessary.

2.2 Recommended

Dosage in Adult Patients The recommended dosage range of VYTORIN 10/10 mg to 10/40 mg once a day.

2.3 Recommended

Dosage in Pediatric Patients 10 Years of Age and Older with HeFH The recommended dosage range of VYTORIN 10/10 mg to 10/40 mg once a day.

2.4 Recommended

Dosage in Patients with Renal Impairment Renal impairment is a risk factor for statin-associated myopathy. Doses of VYTORIN exceeding 10/20 mg should be used with caution and close monitoring in patients with moderate to severe renal impairment. There are no dosage adjustment recommendations for patients with mild renal impairment.

2.5 Dosage Modifications

Due to Drug Interactions Concomitant use of VYTORIN with the following drugs requires dosage modification of VYTORIN. Patients taking Lomitapide Reduce the dosage of VYTORIN by 50%. Do not exceed VYTORIN 10/20 mg once daily (or 10/40 mg once daily for patients who have previously taken VYTORIN 10/80 mg daily chronically while taking lomitapide). Patients taking Verapamil, Diltiazem, or Dronedarone Do not exceed VYTORIN 10/10 mg once daily. Patients taking Amiodarone, Amlodipine, or Ranolazine Do not exceed VYTORIN 10/20 mg once daily. Patients taking Bile Acid Sequestrants In patients taking a bile acid sequestrant, administer VYTORIN at least 2 hours before or 4 hours after the bile acid sequestrant.